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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K150693
Device Name PHIN-FX Cannulated Lag Screw System
Applicant
Ascent Medical, LLC
47801-I-55 N., Suite 100
Jackson,  MS  39211
Applicant Contact DAVID FORD
Correspondent
Engineering Consulting Services, Inc.
3150 E. 200th. St.
Prior Lake,  MN  55372
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received03/18/2015
Decision Date 10/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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